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Which comes first? new study aims to optimize AML treatment sequence

NCT ID NCT05401097

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase II trial is for older adults with a specific type of acute myeloid leukemia (AML) that has IDH gene mutations. Researchers want to find out whether starting treatment with an IDH-targeted drug (ivosidenib or enasidenib) followed by standard therapy (azacitidine plus venetoclax) works better than the reverse order. About 125 participants who cannot have intensive chemotherapy will be randomly assigned to one of the two sequences. The goal is to see which order leads to better disease control and survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ivosidenib, enasidenib, azacitidine, venetoclax
What this could lead to
If successful, this study could identify the best sequence of targeted drugs and standard therapy to improve outcomes for older AML patients with IDH mutations.
What could go wrong
This is a phase II trial with only 125 participants, so results may not apply broadly. The study compares treatment order, not a new drug, so benefits may be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 125 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with newly diagnosed IDH1 or IDH2 mutated AML * Not a candidate for or refuses intensive induction therapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Creatinine clearance \> 40 ml/min * Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) \< 5 x upper limit of normal * Total bilirubin \< 1.5 x upper limit of normal (except for patients with Gilbert's disease) * At the time of Venetoclax initiation, white blood cells (WBC) needs to be \< 25 × 103 microliter: Hydroxyurea can be used to achieve that level. * For female patients of childbearing potential, willingness to abstain from heterosexual intercourse or use a protocol-recommended method of contraception from the screening visit throughout the study treatment period and for 6 months following the last dose of either study drug. A serum pregnancy test will be done at screening. A serum or urine pregnancy test will be done on Day 1 of each cycle for women of childbearing potential. If the urine pregnancy test is positive, a serum pregnancy test must be performed per institutional standards. The following methods are acceptable methods of contraception for the purpose of this study: * Highly Effective Contraception Methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods (Clinical Trials Facilitation Group 2014): * Combined (estrogen and progestin containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal). * Progestin-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable). * Intrauterine device. * Intrauterine hormone-releasing system. * Bilateral tubal occlusion. * Vasectomized partner, provided that partner is the sole sexual partner of the female study participant and that the vasectomized partner has received medical assessment of the surgical success. * Sexual abstinence- only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. * Acceptable Birth Control Methods that are not Highly Effective Contraception Acceptable birth control methods that result in a failure rate of more than 1% per year: * Progestin-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action. * Male or female condom with or without spermicide. * Cap, diaphragm, or sponge with spermicide. A combination of male condom with either cap, diaphragm, or sponge with spermicide (double barrier methods) are also acceptable, but not highly effective, birth control methods. * The following methods are NOT acceptable methods of contraception for the purpose of this study: * Periodic abstinence (calendar, symptothermal, postovulation methods). * Withdrawal (coitus interruptus). * Spermicides only. * Lactational amenorrhea method. * Combination of male and female condom * For male patients of childbearing potential having intercourse with females of childbearing potential, the willingness to abstain from heterosexual intercourse or use a protocol recommended method of contraception from the screening visit throughout the study treatment period and for 3 months following the last dose of either study drug. Males must also refrain from sperm donation from the screening visit throughout the study treatment period and for 3 months following the last dose of either dose of study drug * Willingness to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures and study restrictions Exclusion Criteria: * Patients with acute promyelocytic leukemia * Known active central nervous system involvement of leukemia * Any active malignancy requiring therapy, that would interfere with the interpretation of study endpoints. * Evidence of ongoing uncontrolled systemic bacterial, fungal or viral infection at the time of start of study treatment * Uncontrolled infection with hepatitis C, hepatitis B, or human immunodeficiency virus (HIV) * Pregnancy or breast feeding * Concurrent participation in an investigational drug trial with therapeutic intent defined as prior study therapy within 14 days prior to study treatment * Inability to tolerate oral medications including symptomatic disease significantly affecting gastrointestinal function such as inflammatory bowel disease or resection of stomach or small bowel

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    4 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • UNC Hospitals, University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

    Contact Email: •••••@•••••

  • UT Southwestern Medical Center at Dallas

    RECRUITING

    Dallas, Texas, 75235, United States

  • University of Colorado

    RECRUITING

    Aurora, Colorado, 80205, United States

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